510(k) K032064 ยท MQP Spinal Vertebral Body Replacement Device
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
| Applicant | Theken Surgical,Llc, Akron OH, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Jul 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | Integra LifeSciences Corp. Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System
The Theken CPOD / LPOD VBR is indi Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.